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Clinical Research Associate

Employer
Prometheus Biosciences
Location
San Diego, California
Start date
Apr 20, 2022

View more

Discipline
Clinical, Clinical Research, Regulatory
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
Biotech Beach, Best Places to Work

Job Details

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Clinical Research Associate - San Diego, California

 

We’re a different kind of biotech company.  And we’re here to make a difference.

 

Prometheus Biosciences, Inc. (Nasdaq: RXDX), is a clinical-stage biotechnology company pioneering a precision medicine approach for the discovery, development, and commercialization of novel therapeutic and companion diagnostic products for the treatment of immune-mediated diseases. 

 

The Company’s precision medicine platform, Prometheus360™, combines proprietary machine learning-based analytical approaches with one of the world’s largest gastrointestinal bioinformatics databases to identify novel therapeutic targets and develop therapeutic candidates to engage those targets. Prometheus Biosciences was named Best Places to Work by Biospace in 2022 and is headquartered in San Diego, CA. 

 

Summary

Responsible for providing Clinical Research support for all Prometheus sponsored clinical trials.  This position will serve as the primary support for the clinical study team.

 

Responsibilities

  • Participate and assist in design and preparation of protocols and case report forms.
  • Generate clinical SOPs, policies, charters, and plans according to US and international guidelines.
  • Participate in the evaluation of potential clinical sites according to established criteria of acceptability.
  • Responsible for procurement of budgets, contracts, regulatory documents, and other administrative documents as related to clinical research functions.
  • Initiate studies performing initiation site visits, arrange for shipment of clinical supplies, case report forms, and other necessary materials.
  • Conduct ongoing study monitoring, including frequent periodic site visits, protocol adherence checks, material handling procedures, inspection of study files, and related monitoring functions.
  • Prepare site visit reports with identification of key accomplishments, key issues for resolution and recommendations for follow-up actions for assigned study sites.
  • Conduct study termination visits, obtain final reports from investigators, and participate in the preparation of final reports for regulatory submission.
  • Assist with the maintenance of clinical archive and electronic files.

 

Education and Experience

  • Bachelor’s degree, RN BSN or equivalent
  • Basic knowledge and adherence to GCPs
  • Two or more years of clinical research experience in biopharmaceutical Industry

 

Essential Skills and Abilities

  • Unquestionable integrity, be able to inspire trust and exhibit the highest ethical standards
  • Strong attention to detail
  • Ability to multi-task in a fast-paced, entrepreneurial, smaller company environment
  • Excellent communication, verbal and written, and interpersonal skills with strong ability to interact with internal teams and partners across the organization
  • Ability to effectively present information and respond to questions from all levels of the organization
  • Sense of urgency, flawless execution with intense focus on accuracy and accountability
  • Self-starter, highly motivated, assertive, driven and hands-on leader
  • Operate collaboratively with colleagues across functional areas in a science-driven environment
  • Ability to work across locations and time zones
  • Travel up to 25% may be required

 
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Company

 

 

Company info
Website
Phone
(858) 824-0895
Location
3050 Science Park Road
San Diego
CA
92121
United States

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